An interventional study of Prism Glasses and Non-Prism Glasses in Exotropia Intermittent, sponsored by Jaeb Center for Health Research. Completed at 28 sites in United States. Open to participants aged 3 Years to 13 Years. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Jaeb Center for Health Research · Not applicable, Interventional, and Treatment
The objective of this short-term, pilot randomized trial comparing spectacles with relieving prism to spectacles without prism is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to prism by comparing treatment groups on the following outcomes:
Intermittent Exotropia meeting all of the following criteria:
Refractive correction (must be worn for at least 1 week if refractive error meets any of the following (based on a cycloplegic refraction performed within 7 months but prior to the day of enrollment):
If spectacles have been prescribed and are worn, they must meet the following pre- enrollment criteria:
Exclusion Criteria:
Additional Eligibility Criteria for Randomization Based on Prism Adaptation Testing
Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant
Device: Prism Glasses
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Device: Non-Prism Glasses
Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
Exotropia Control Score at Distance, Continuous Score
The primary analysis will be an intent-to-treat comparison of mean 8-week control of the distance exodeviation (average of 3 measurements) between treatment groups using an analysis of covariance (ANCOVA) model, which adjusts for baseline distance control. Distance control scores range from 0 to 5 with higher scores indicating a worse outcome.
Time frame: 8 weeks
Exotropia Control Score at Distance, % With Treatment Response
The secondary analysis will calculate the percentage of participants with a "treatment response," defined as ≥1 point improvement in control of their distance exodeviation (average of 3 measurements) between baseline and the 8-week outcome exam.
Time frame: 8 weeks
Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia
The proportion of participants with no spontaneous tropia at 8 weeks will be compared between treatment groups using a two-sided Barnard's test with alpha of 0.05, with calculation of a two-sided 95% confidence interval on the difference in proportions. No spontaneous tropia at the 8-week primary outcome exam is defined as a score of ≤2 (0, 1, or 2) on all three assessments of control at distance and at near.
Time frame: 8 Weeks
Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks
Control of the exodeviation was measured at distance using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used. The change in distance control from baseline to 8 weeks will be calculated. A negative value indicates improvement.
Time frame: 8 Weeks
Exotropia Control Score at Near, Continuous Score
Near control will be evaluated similarly to the primary outcome and outcome measures 2-4. Near control scores range from 0 to 5 with higher scores indicating a worse outcome.
Time frame: 8 Weeks
Exodeviation by PACT at Distance, Continuous
The measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Time frame: 8 Weeks
Exodeviation by PACT at Near, Continuous
The measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Time frame: 8 Weeks
Randot Preschool Stereoacuity at Near, Continuous
Randot® Preschool Stereoacuity test (Stereo Optical Co., Inc., Chicago, IL). For analysis, stereoacuity was converted from seconds of arc scores to log arcsec values (in parentheses) as follows: 40 (1.60), 60 (1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90); participants with no detectable (nil) stereoacuity were assigned the value of 1600 (3.20). The measure of Randot Preschool Stereoacuity at near will be summarized at 8 weeks for each treatment group. A lower score is better.
Time frame: 8 Weeks
Compliance of Spectacle Wear
Parents will be asked to complete a compliance calendar by recording the percentage of time their child has worn the study-prescribed spectacle correction each day. Proportion of time worn each day will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%). Based on review of the calendars and discussion with parents at the 8-week outcome exam, the investigator will record the total proportion of time worn as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%: did not fill prescription or never picked up spectacles). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time frame: 8 weeks
Child Assessment of Symptoms - Do Your Eyes Hurt?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Child Assessment of Symptoms - Do You Have Double Vision?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time frame: 8 Weeks
Distance Visual Acuity (Snellen Equivalent)
Distance visual acuity will be assessed at the 8-week outcome exam. Any optotype method can be used for testing. The distribution of distance visual acuity Snellen Equivalents will be tabulated for each treatment group. A lower Snellen Equivalent is best.
Time frame: 8 Weeks
Fusional Convergence - Continuous Break Point
As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery point is better than a higher number.
Time frame: 8 Weeks
Suppression
The suppression assessment is a standardized method of assessing the depth of suppression experienced while the participant is tropic (NOT aligned). Scoring is reported on an ordinal scale from 0 (no suppression) to 3 (dense suppression). "Missing" refers to cases in which participants were unable to understand the test and/or gave unreliable responses. As an exploratory analysis, the distribution of suppression level (none, mild, moderate, severe, missing) will be tabulated after 8 weeks by treatment group.
Time frame: 8 Weeks
Fusional Convergence - Continuous Recovery Point
As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery is better than a higher number.
Time frame: 8 Weeks
Between 09/01/2019 and 07/30/2020, 61 participants were enrolled into the study across 28 clinical sites. After prism-adaptation testing to confirm eligibility, 4 participants did not meet eligibility criteria and 57 participants were randomized to receive either 40% base-in prism spectacles (n=28) or non-prism spectacles (n=29).
| Milestone | Prism Group | Non-Prism Group |
|---|---|---|
| Started | 28 | 29 |
| Completed | 25 | 25 |
| Not completed | 3 | 4 |
The primary analysis will be an intent-to-treat comparison of mean 8-week control of the distance exodeviation (average of 3 measurements) between treatment groups using an analysis of covariance (ANCOVA) model, which adjusts for baseline distance control. Distance control scores range from 0 to 5 with higher scores indicating a worse outcome.
| units on a scale | Prism Group | Non-Prism Group |
|---|---|---|
| Exotropia Control Score at Distance, Continuous Score | 3.6 ± 1.3 | 3.3 ± 1.5 |
The secondary analysis will calculate the percentage of participants with a "treatment response," defined as ≥1 point improvement in control of their distance exodeviation (average of 3 measurements) between baseline and the 8-week outcome exam.
| percentage of participants | Prism Group | Non-Prism Group |
|---|---|---|
| Exotropia Control Score at Distance, % With Treatment Response | 32 | 24 |
The proportion of participants with no spontaneous tropia at 8 weeks will be compared between treatment groups using a two-sided Barnard's test with alpha of 0.05, with calculation of a two-sided 95% confidence interval on the difference in proportions. No spontaneous tropia at the 8-week primary outcome exam is defined as a score of ≤2 (0, 1, or 2) on all three assessments of control at distance and at near.
| percentage of participants | Prism Group | Non-Prism Group |
|---|---|---|
| Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia | 48 | 51 |
Control of the exodeviation was measured at distance using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used. The change in distance control from baseline to 8 weeks will be calculated. A negative value indicates improvement.
| units on a scale | Prism Group | Non-Prism Group |
|---|---|---|
| Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks | 0.1 ± 1.4 | -0.2 ± 1.5 |
Near control will be evaluated similarly to the primary outcome and outcome measures 2-4. Near control scores range from 0 to 5 with higher scores indicating a worse outcome.
| units on a scale | Prism Group | Non-Prism Group |
|---|---|---|
| Exotropia Control Score at Near, Continuous Score | 1.7 ± 1.1 | 1.7 ± 1.3 |
The measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
| prism diopters | Prism Group | Non-Prism Group |
|---|---|---|
| Exodeviation by PACT at Distance, Continuous | 30.6 ± 9.3 | 26.5 ± 8.1 |
The measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
| prism diopters | Prism Group | Non-Prism Group |
|---|---|---|
| Exodeviation by PACT at Near, Continuous | 28.7 ± 8.2 | 19.0 ± 9.8 |
Randot® Preschool Stereoacuity test (Stereo Optical Co., Inc., Chicago, IL). For analysis, stereoacuity was converted from seconds of arc scores to log arcsec values (in parentheses) as follows: 40 (1.60), 60 (1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90); participants with no detectable (nil) stereoacuity were assigned the value of 1600 (3.20). The measure of Randot Preschool Stereoacuity at near will be summarized at 8 weeks for each treatment group. A lower score is better.
| log arc seconds | Prism Group | Non-Prism Group |
|---|---|---|
| Randot Preschool Stereoacuity at Near, Continuous | 2.2 ± 0.4 | 1.9 ± 0.4 |
Parents will be asked to complete a compliance calendar by recording the percentage of time their child has worn the study-prescribed spectacle correction each day. Proportion of time worn each day will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%). Based on review of the calendars and discussion with parents at the 8-week outcome exam, the investigator will record the total proportion of time worn as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%: did not fill prescription or never picked up spectacles). The distribution of compliance will be assessed for each treatment group at the outcome exam.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Excellent (76% to 100%) | 22 | 22 |
| Good (51% to 75%) | 3 | 2 |
| Fair (26% to 50%) | 0 | 1 |
| Poor (1% to 25%) | 0 | 0 |
| None (0%) | 0 | 0 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 15 | 22 |
| Sometimes | 6 | 3 |
| Almost Always | 4 | 0 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 17 | 20 |
| Sometimes | 7 | 3 |
| Almost Always | 1 | 2 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 17 | 17 |
| Sometimes | 8 | 7 |
| Almost Always | 0 | 1 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 16 | 15 |
| Sometimes | 7 | 8 |
| Almost Always | 2 | 2 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 11 | 14 |
| Sometimes | 8 | 5 |
| Almost Always | 6 | 6 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 20 | 19 |
| Sometimes | 2 | 3 |
| Almost Always | 3 | 3 |
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 16 | 12 |
| Sometimes | 5 | 11 |
| Almost Always | 4 | 2 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 15 | 14 |
| Almost Never | 8 | 6 |
| Sometimes | 2 | 5 |
| Often | 0 | 0 |
| Almost Always | 0 | 0 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 16 | 11 |
| Almost Never | 5 | 4 |
| Sometimes | 4 | 9 |
| Often | 0 | 1 |
| Almost Always | 0 | 0 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 22 | 15 |
| Almost Never | 2 | 6 |
| Sometimes | 0 | 3 |
| Often | 1 | 1 |
| Almost Always | 0 | 0 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 21 | 21 |
| Almost Never | 2 | 3 |
| Sometimes | 1 | 1 |
| Often | 1 | 0 |
| Almost Always | 0 | 0 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 12 | 14 |
| Almost Never | 7 | 3 |
| Sometimes | 5 | 5 |
| Often | 0 | 3 |
| Almost Always | 1 | 0 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 5 | 10 |
| Almost Never | 11 | 5 |
| Sometimes | 6 | 8 |
| Often | 3 | 1 |
| Almost Always | 0 | 1 |
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| Never | 17 | 14 |
| Almost Never | 3 | 5 |
| Sometimes | 5 | 5 |
| Often | 0 | 1 |
| Almost Always | 0 | 0 |
Distance visual acuity will be assessed at the 8-week outcome exam. Any optotype method can be used for testing. The distribution of distance visual acuity Snellen Equivalents will be tabulated for each treatment group. A lower Snellen Equivalent is best.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| 20/16 (best) | 3 | 1 |
| 20/20 | 10 | 9 |
| 20/25 | 9 | 8 |
| 20/32 | 2 | 3 |
| 20/40 | 1 | 4 |
As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery point is better than a higher number.
| prism diopters | Prism Group | Non-Prism Group |
|---|---|---|
| Fusional Convergence - Continuous Break Point | 17.8 ± 11.5 | 17.5 ± 10.9 |
The suppression assessment is a standardized method of assessing the depth of suppression experienced while the participant is tropic (NOT aligned). Scoring is reported on an ordinal scale from 0 (no suppression) to 3 (dense suppression). "Missing" refers to cases in which participants were unable to understand the test and/or gave unreliable responses. As an exploratory analysis, the distribution of suppression level (none, mild, moderate, severe, missing) will be tabulated after 8 weeks by treatment group.
| Participants | Prism Group | Non-Prism Group |
|---|---|---|
| None (0 suppression) | 1 | 5 |
| Mild (1 suppression) | 5 | 3 |
| Moderate (2 suppression) | 6 | 4 |
| Dense (3 suppression) | 12 | 10 |
| Missing | 1 | 3 |
As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery is better than a higher number.
| prism diopters | Prism Group | Non-Prism Group |
|---|---|---|
| Fusional Convergence - Continuous Recovery Point | 9.4 ± 10.1 | 10.6 ± 9.4 |
Collected over Adverse events were monitored/assessed from the participant's perspective between randomization and completion of their 8-week primary outcome visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prism Group | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Non-Prism Group | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| <=18 years | 28 | 29 | 57 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| Mean | 6.4 ± 2.4 | 6.8 ± 2.1 | 6.6 ± 2.2 |
| Age, Customized(Participants) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| 3 to <5 years | 10 | 7 | 17 |
| 5 to <7 years | 7 | 10 | 17 |
| 7 to <9 years | 8 | 8 | 16 |
| >=9 years | 3 | 4 | 7 |
| Sex: Female, Male(Participants) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| Female | 17 | 16 | 33 |
| Male | 11 | 13 | 24 |
| Race/Ethnicity, Customized(Participants) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| Asian | 0 | 3 | 3 |
| Black/African American | 6 | 2 | 8 |
| Hispanic | 4 | 7 | 11 |
| White | 16 | 17 | 33 |
| More than one race | 2 | 0 | 2 |
| Region of Enrollment(participants) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| United States | 28 | 29 | 57 |
| Refractive Error Average of Eyes, Continuous(Spherical Equivalent Diopters) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| Mean | 0.3 ± 1.0 | 0.1 ± 1.4 | 0.2 ± 1.2 |
| Refractive Error Average of Eyes, Categorical(Participants) | Prism Group | Non-Prism Group | Total |
|---|---|---|---|
| -6.00 to <-2.00 diopters | 1 | 3 | 4 |
| -2.00 to <-1.00 diopters | 2 | 0 | 2 |
| -1.00 to <-0.00 diopters | 4 | 4 | 8 |
| 0.00 to <1.00 diopters | 12 | 16 | 28 |
| 1.00 to <2.00 diopters | 9 | 6 | 15 |
12 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Jaeb Center for Health Research